Breast CancerAROMA NEUROTAXNCT07779135
Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN)
An observational study of Breast Cancer and Neuropathic Pain in Cancer, run by Centre Hospitalier de Colmar at 1 site in France.
Trial summary
The main objective of this study is to describe the effect of an essential oil-based blend applied topically in the management of painful symptoms, sensory disturbances, or functional impairment caused by Chemotherapy-Induced Neuropathy (CIN) in breast cancer patients who have undergone paclitaxel treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neuropathic Pain in Cancer
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2026to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with breast cancer attending at Colmar Hospital
Who may be able to join
- Female patients with breast cancer
- who have painful or bothersome CIN
- occurring in the context of paclitaxel treatment (during or after treatment)
- for whom conventional drug treatments provide insufficient relief (or are poorly tolerated or refused).
- Age ≥ 18 years
- Who, after receiving information, do not object to the use of their data for the purposes of this research
Who cannot join
- Pre-existing neuropathy (e.g., due to diabetes)
- Known allergy to an essential oil or a component of essential oils (e.g., linalool)
- Presence of wounds on the affected areas
- Refusal to use aromatherapy
- Inability to complete the questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Magali Eyriey contact
France1 site, 1 recruiting
- Recruiting
Hôpitaux Civils de Colmar
Colmar, 68024
Karine Demesmay, +33389124963 ext. +33, karine.demesmay@ch-colmar.fr
Magali Eyriey, +33389124810, cellule-promotion@ch-colmar.fr
About this study
Official title: Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN) in Patients Receiving Taxane Therapy for Breast Cancer.
The main objective of this study is to describe the effect of an essential oil-based blend applied topically in the management of painful symptoms, sensory disturbances, or functional impairment caused by Chemotherapy-Induced Neuropathy (CIN) in breast cancer patients who have undergone paclitaxel treatment.
- Conditions
- Breast Cancer, Neuropathic Pain in Cancer
- Keywords
- Chemotherapy-Induced Neuropathy, Breast cancer, Aromatherapy
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory and pain-related symptoms evolution measured with CIPN20
The CIPN20 (Chemotherapy-Induced Peripheral Neuropathy) questionnaire is a 20-item questionnaire used to assess and monitor symptoms, specifically targeting chemotherapy-induced neuropathies.
We will limit ourselves to items 31 through 44, which concern sensory and pain-related symptoms.
Items 31-36, 39, and 40 address sensory symptoms and problems. Items 37, 38, 41-44 address motor symptoms and problems. The individual items should be scored such that higher scores represent more symptoms/problems (i.e., higher score = worse).
Measured: At enrollment, Day 7 and Day 30 follow-up
Secondary outcomes (4)
Quality of life measured with EORTC QLQ C30
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: At enrollment, Day 7 and Day 30 follow-up
Patient's perceived health status measured with PGI-C
The patient's perceived health status will be assessed using the Patients' Global Impression of Change questionnaire (PGI-C). PGI-C is the PRO counterpart to the Clinical Global Impressions scale, (CGI), which was published in 1976 by the National Institute of Mental Health (US). PGI-C is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved" (1 point), "much improved" (2 points), "minimally improved" (3 points), "no change" (4 points), "minimally worse" (5 points), "much worse" (6 points) or "very much worse" (7 points).
Measured: At Day 7 and Day 30 follow-up
Anxiety and depression level measured with HAD
The HAD Scale is a tool used to screen for anxiety and depressive disorders. It consists of 14 items scored on a scale of 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), resulting in two scores (maximum score for each = 21).
Measured: At enrollment, Day 7 and Day 30 follow-up
Satisfaction, adherence and adverse events measured with a specific survey
A survey on satisfaction, adherence and adverse events will be conducted using a specific qualitative questionnaire that employs a Likert scale for certain items (acceptance, satisfaction).
For acceptance, a 4-point scale of likert will be used : 1 = "Strongly agree", 2 = "Agree", 3 = "Disagree", 4 = "Strongly disagree".
For overall satisfaction, a 6-point scale will be used, ranging from 1 (very dissatisfied) to 6 (very satisfied).
Measured: At Day 7 and Day 30 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Jul 2026
- Primary completion15 May 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Colmar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Demesmay, Principal investigator, Hopitaux Civils de ColmarEmilie Hutt, Principal investigator, Hopitaux Civils de Colmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779135
- Sponsor's protocol ID
- HCC-023
- Other IDs
- 2026-A01296-45
- Acronym
- AROMA NEUROTAX
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN) in Patients Receiving Taxane Therapy for Breast Cancer.
- ClinicalTrials.gov ID
- NCT07779135
- Acronym / sponsor ID
- AROMA NEUROTAX / HCC-023
- Conditions
- Breast Cancer, Neuropathic Pain in Cancer
- Keywords
- Chemotherapy-Induced Neuropathy, Breast cancer, Aromatherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ColmarUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to describe the effect of an essential oil-based blend applied topically in the management of painful symptoms, sensory disturbances, or functional impairment caused by Chemotherapy-Induced Neuropathy (CIN) in breast cancer patients who have undergone paclitaxel treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with breast cancer attending at Colmar Hospital
Key inclusion criteria (6 listed)
- Female patients with breast cancer
- who have painful or bothersome CIN
- occurring in the context of paclitaxel treatment (during or after treatment)
- for whom conventional drug treatments provide insufficient relief (or are poorly tolerated or refused).
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Pre-existing neuropathy (e.g., due to diabetes)
- Known allergy to an essential oil or a component of essential oils (e.g., linalool)
- Presence of wounds on the affected areas
- Refusal to use aromatherapy
- Inability to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory and pain-related symptoms evolution measured with CIPN20
Time frame: At enrollment, Day 7 and Day 30 follow-up
The CIPN20 (Chemotherapy-Induced Peripheral Neuropathy) questionnaire is a 20-item questionnaire used to assess and monitor symptoms, specifically targeting chemotherapy-induced neuropathies. We will limit ourselves to items 31 through 44, which concern sensory and pain-related symptoms. Items 31-36, 39, and 40 address sensory symptoms and problems. Items 37, 38, 41-44 address motor symptoms and problems. The individual items should be scored such that higher scores represent more symptoms/problems (i.e., higher score = worse).
4 secondary outcomes
Quality of life measured with EORTC QLQ C30
Time frame: At enrollment, Day 7 and Day 30 follow-up
Patient's perceived health status measured with PGI-C
Time frame: At Day 7 and Day 30 follow-up
Anxiety and depression level measured with HAD
Time frame: At enrollment, Day 7 and Day 30 follow-up
Satisfaction, adherence and adverse events measured with a specific survey
Time frame: At Day 7 and Day 30 follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magali Eyriey contact
Karine Demesmay principal investigator
Hopitaux Civils de Colmar
Emilie Hutt principal investigator
Hopitaux Civils de Colmar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Neuropathic Pain in Cancer, run by Centre Hospitalier de Colmar at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine Demesmay (+33 3 89 12 42 40, karine.demesmay@ch-colmar.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory and pain-related symptoms evolution measured with CIPN20 (time frame: At enrollment, Day 7 and Day 30 follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.